FDA Drug recall D-1077-2019
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West De…
- FDA Drug
- Class II
- terminated
- Published 2019-04-10
On 2019-04-10 the FDA classified a Class II recall of Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West De… by Johnson Matthey, citing microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1077-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-05 |
| Published | 2019-04-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Johnson Matthey |
| Distribution | US |
Product
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
Reason
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Identifiers
| code_info | Lot# B1414-160809, Retest Date AUG 2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1077-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.